Application 088262

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088262-001	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		1983-10-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A088262-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088262-001	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1983-10-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A088262-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088262-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088262-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088262-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088262-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088262-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088262-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088262-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088262-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088262-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088262-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088262-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088262-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088262-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088262-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088262-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088262-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088262-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088262-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088262-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088262-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088262-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088262-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088262-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088262-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088262-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088262-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088262-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088262-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088262-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088262-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088262-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088262-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088262-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088262-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088262-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088262-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088262-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088262-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088262-001	AB	1	`e64feba35796…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Strides Pharma Science Limited	51d3b181-0d15-4782-a966-feb137972b18	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088262 application number: ANDA088262 ndc (product): 64380-170

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-055	Imipramine Hydrochloride	Imipramine Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-055	Imipramine Hydrochloride	Imipramine Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-055	Imipramine Hydrochloride	Imipramine Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
50090-0034	Imipramine Hydrochloride	Imipramine Hydrochloride	A-S Medication Solutions	ANDA	Current
60429-096	Imipramine Hydrochloride	Imipramine Hydrochloride	Golden State Medical Supply, In.c	ANDA	Current
60429-096	Imipramine Hydrochloride	Imipramine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-096	Imipramine Hydrochloride	Imipramine Hydrochloride	Golden State Medical Supply, In.c	ANDA	Current
60429-096	Imipramine Hydrochloride	Imipramine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
63629-2209	Imipramine Hydrochloride	Imipramine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2209	Imipramine Hydrochloride	Imipramine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2209	Imipramine Hydrochloride	Imipramine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
64380-170	Imipramine Hydrochloride	Imipramine Hydrochloride	Strides Pharma Science Limited	ANDA	Current
70518-1793	Imipramine Hydrochloride	Imipramine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1793	Imipramine Hydrochloride	Imipramine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1793	Imipramine Hydrochloride	Imipramine Hydrochloride	REMEDYREPACK INC.	ANDA	Current